Bone Screws, Instrumentation, and Methods of Using of Same

ABSTRACT

A method of inserting a fastener includes positioning a portion of a stylet within a cannulated shaft of the fastener, advancing a tip of the stylet through a first bone and into a second bone, advancing a leading end of the fastener along the stylet through the first bone and into the second bone, and removing the stylet from the cannulated shaft of the fastener and the bone. In another embodiment, a method of inserting a fastener includes positioning a portion of a stylet within a cannulated shaft of the fastener, advancing a tip of the stylet into a bone to a first depth without advancing the fastener into the bone, advancing a leading end of the fastener along the stylet into the bone to a second depth without further advancing the stylet into the bone, and removing the stylet from the cannulated shaft of the fastener and the bone.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.16/810,911, filed on Mar. 6, 2020, and this application claims thebenefit of the filing date of U.S. Provisional Patent Application No.62/814,505 filed on Mar. 6, 2019, both of which are hereby incorporatedby reference herein.

BACKGROUND OF THE INVENTION

The present invention generally relates to fixation devices, and moreparticularly, to spinal fasteners for single step insertion.

A technique commonly referred to as spinal fixation is employed forfusing together and/or mechanically immobilizing vertebrae of the spine.Spinal fixation may also be used to alter the alignment of adjacentvertebrae relative to one another so as to change the overall alignmentof the spine. Such techniques have been used effectively to treat manydegenerative conditions and, in most cases, to relive pain suffered bythe patient.

In some applications, a surgeon will install pedicle screws into thepedicles of adjacent vertebrae (along one or multiple levels of thespine) and thereafter connect the screws with a spinal rod in order toimmobilize and stabilize the vertebral column Whether conducted inconjunction with interbody fusion or across single or multiple levels ofthe spine, the use of pedicle screws connected by fixation rods is animportant treatment method employed by surgeons.

There remains room for improvement in the design and use of pediclescrews, particularly for surgical efficiency while maintaining safetyand accuracy during screw insertion.

BRIEF SUMMARY OF THE INVENTION

According to an embodiment of the present disclosure, a method of spinalrepair includes the steps of inserting a stylet through a lumen of ascrew such that a distal tip of the stylet extends distally from adistal end of the screw, the stylet extending along an axis; advancingthe screw and the stylet toward a bone until the distal tip of thestylet contacts the bone; and rotating the screw about the axis of thestylet in a first direction and simultaneously oscillating rotation ofthe stylet about the axis between the first direction and a seconddirection opposite to the first direction.

In other embodiments, the step of rotating may include advancing thescrew into bone. The step of oscillating may include retracting thestylet away from the bone. When the screw is rotated in the firstdirection and the stylet is rotated in the second direction, the screwand the stylet may move in opposite directions along the axis. Themethod may include the step of removing the stylet from the bone. Thescrew may have a distal cutting edge. The method may include the step ofinserting the stylet into the bone to a depth that is less than anintended insertion depth of the screw.

Another embodiment of the disclosure includes a system for spinalrepair. The system includes a screwdriver that includes a drill adaptorthat has an internal surface and is rotatable in a first direction and asecond direction opposite the first direction. The screwdriver includesa gear system that has a driving gear, a driven gear, and one or moreconnector gears, the driving gear has a splined internal surface and anexternal surface configured to mate with the internal surface of thedrill adaptor such that rotation of the drill adaptor causes rotation ofthe driving gear in the same direction. The driven gear has a splinedinternal surface, the driving gear and the driven gear are connected bythe one or more connector gears such that rotation of the driving gearcauses rotation of the driven gear in the opposite direction. Thescrewdriver includes a first ratchet pawl that has a splined outersurface configured to engage the splined inner surface of the drivinggear and a second ratchet pawl that has a splined outer surfaceconfigured to engage the splined inner surface of the driven gear. Thefirst and second ratchet pawls are splined in the same direction suchthat when one of the driving gear and the driven gear engages therespective first or second pawl, the other gear is disengaged from therespective first or second pawl. A shaft is connected to the first andsecond ratchet pawls. The system also includes a stylet that has athreaded portion and a housing surrounding the first and second ratchetpawls and rotationally locked relative to the shaft. The housing has athreaded inner surface to engage the threaded portion of the stylet.

In other embodiments, the first and second ratchet pawls may eachconnected to the shaft by a pin. The shaft may rotate in a singledirection. Rotation of the drill adaptor may cause rotation of thestylet in the same direction as the drill adaptor. The threaded portionof the stylet may include threads having the same pitch as internalthreads of the threaded portion of the housing. Rotation of the drilladaptor in the first direction about the axis may cause the stylet toremain axially fixed and rotation of the drill adaptor in the seconddirection about the axis may cause the stylet to retract axially. Thesystem may include a fastener defining a lumen for receiving the stylet.Rotation of the drill adaptor in the first direction and the seconddirection about the axis may cause the bone screw to advance into thebone. The fastener may include a channel adapted to receive a spinalrod, a shaft extending from the head to a distal tip, the distal tiphaving at least one cutting edge.

Another embodiment of the present disclosure includes a fastener thatincludes a head which has a channel adapted to receive a spinal rod, anda shaft extending from the head to a distal tip. The shaft has a thread,and the distal tip has at least one cutting edge.

In other embodiments, the fastener may be cannulated. The threads maycontinuously transition into the at least one cutting edge. The threadsmay terminate at a location spaced apart from the at least one cuttingedge.

Yet another embodiment of the present disclosure includes a styletcontrol system for selectively advancing and retracting a stylet thatincludes a stylet that has a first end and a second end. The second endis threaded. The system includes a screwdriver that defines a bore forreceiving the stylet and has a screw-engaging end for engaging a screw,the stylet is rotationally fixed relative to the screwdriver. The systemincludes a control device that is attachable to the screwdriver and hasan inner surface defining a lumen for receiving the stylet. A portion ofthe inner surface is threaded for engaging the threaded second end ofthe stylet. When the control device is rotated in a first rotationdirection and the screwdriver is prevented from rotating, the styletadvances in a first axial direction, and when the screwdriver is rotatedin the first rotation direction and the control device is prevented fromrotating, the screwdriver advances the screw in the first axialdirection and the stylet retracts in a second axial direction, oppositethe first axial direction.

In other embodiments, the threaded portion of the stylet may be anintegral and monolithic part of the stylet. The stylet may be keyed andthe screwdriver includes a corresponding keyed feature such as a hexfeature on an inner surface to rotatably lock the stylet to thescrewdriver. The system may include a quick connect feature to couplethe control device to the screwdriver. The control device and thescrewdriver may each include a robotic end effector.

Yet another embodiment of the present disclosure includes a styletcontrol system for selectively advancing and retracting a stylet thatincludes a stylet that has a first end and a second end. The second endis threaded. The system includes a screwdriver that defines a bore forreceiving a portion of the stylet and has a screw-engaging end forengaging a screw, the stylet is rotationally fixed relative to thescrewdriver. The system includes a control device that is operativelyconnected to the screwdriver and has an inner portion defining a lumenfor receiving the portion of the stylet. The inner portion is threadedfor engaging the threaded second end of the stylet. When the screwdriveris rotated in the first rotation direction and the control device isprevented from rotating, the screwdriver advances the screw in the firstaxial direction and the stylet retracts in a second axial direction,opposite the first axial direction.

In other embodiments, the stylet may be keyed and the screwdriverincludes a corresponding keyed feature such as a hex feature on an innersurface to rotatably lock the stylet to the screwdriver. The system mayinclude a robotic end effector and a cap to couple the screwdriver tothe robotic end effector. The control device may be operativelyconnected to a robotic end effector. The control device may include anultrasonic transducer for imparting an ultrasonic force to the stylet.The ultrasonic transducer may be positioned within a housing of thecontrol device. The ultrasonic transducer may be detachable from andexternal to a housing of the control device. The ultrasonic transducermay include piezoelectric material. The inner portion of the controldevice may include at least one threaded pawl for engagement with thethreads of the stylet. The system may be part of a kit which includes arobotic end effector. The kit may include a bone screw attachable to thescrewdriver. The bone screw may be self-drilling. The bone screw may becannulated. The control system of the kit may include an ultrasonictransducer for imparting an ultrasonic force to the stylet.

Yet another embodiment of the present disclosure includes a styletcontrol system for selectively advancing and retracting a styletincluding a stylet having a first end and a second end, a screwdriverdefining a bore for receiving the stylet and having a screw-engaging endfor engaging a screw, the stylet being rotationally fixed relative tothe screwdriver, robotic end effector having a passage therethrough, acap configured to be received within a portion of the passage of therobotic end effector and being operatively connected to the screwdriver,a retraction feeder receivable within a lumen of the cap and having amating engagement member for engaging the engagement member of thestylet, when the screwdriver is rotated in a first rotation direction,the screwdriver advances the screw in the first axial direction and thestylet engages the engagement member of the retraction feeder to retractthe stylet in a second axial direction, opposite the first axialdirection.

In other embodiments, the engagement members of the stylet andretraction feeders may include mating threads, and the retraction feederincludes a threaded pawl for one-way engagement of the threaded stylet.The stylet may be keyed and the screwdriver may include a correspondingkeyed feature such as a hex feature on an inner surface to rotatablylock the stylet to the screwdriver. The control system may furtherinclude an ultrasonic transducer for imparting an ultrasonic force tothe stylet. The retraction feeder may be rotatably locked within the endeffector.

Another embodiment of the present disclosure includes a stylet controlsystem for selectively advancing and retracting a stylet including astylet having a first end and a second end, the second end beingthreaded, a screwdriver defining a bore for receiving the stylet andhaving a screw-engaging end for engaging a screw, the stylet beingrotationally fixed relative to the screwdriver, a robotic end effectorhaving a passage therethrough, a cap configured to be received within aportion of the passage of the robotic end effector and being operativelyconnected to the screwdriver, and a retraction feeder receivable withina lumen of the cap and having a threaded pawl for one-way engagementwith the threads of the second end of the stylet, when the screwdriveris rotated in a first rotation direction, the screwdriver advances thescrew in the first axial direction and the threads of the stylet engagesthe threaded pawl of the retraction member to retract the stylet in asecond axial direction, opposite the first axial direction.

In yet another embodiment of the present disclosure, a method ofinserting a fastener positioning a portion of a stylet within acannulated shaft of the fastener, advancing a tip of the stylet througha first bone and into a second bone, advancing a leading end of thefastener along the stylet through the first bone and into the secondbone, and removing the stylet from the cannulated shaft of the fastenerand the bone.

In other embodiments, the step of advancing the tip of the stylet mayinclude traversing a gap between the first bone and the second bone. Thestep of advancing the leading end of the fastener may include traversingthe gap between the first bone and the second bone along the stylet. Thefirst bone and the second bone may be respective vertebral pedicles. Thestep of advancing the tip of the stylet may include advancing the tip ofthe stylet into the second bone to a first depth. The step of advancingthe leading end of the fastener may include advancing the leading end ofthe fastener into the second bone to a second depth, wherein the seconddepth is less than the first depth. The step of advancing the tip of thestylet may include pushing and/or oscillating the stylet through thefirst bone and into the second bone, and may further include the step ofadvancing the leading end of the fastener by rotating the fastener toengage threads of the fastener with the first bone and the second bone.The step of advancing the leading end of the fastener may includemaintaining a stationary position of the stylet in the first bone andthe second bone. The step of advancing the tip of the stylet may beperformed by a robotic end effector.

In yet another embodiment of the present disclosure, a method ofinserting a fastener includes positioning a portion of a stylet within acannulated shaft of the fastener, advancing a tip of the stylet into abone to a first depth without advancing the fastener into the bone,advancing a leading end of the fastener along the stylet into the boneto a second depth without further advancing the stylet into the bone,and removing the stylet from the cannulated shaft of the fastener andthe bone.

In other embodiments, the step of positioning the portion of the styletmay include positioning the portion of the stylet within a channel ofthe cannulated shaft of the fastener. The step of advancing the tip ofthe stylet may include forming a pilot hole into the bone with thestylet. The step of advancing the tip of the stylet may includemaintaining a leading end of the fastener at or above a surface of thebone. The first depth may be between 5 to 30 millimeters. The seconddepth may be less than the first depth. The step of advancing theleading end of the fastener may include the stylet remaining axiallyfixed within the bone. The step of advancing the tip of the stylet maybe performed by a robotic end effector. The step of advancing the tip ofthe stylet may include pushing and/or oscillating the stylet through thebone, and may further include the step of advancing the leading end ofthe fastener by rotating the fastener to engage threads of the fastenerwith the bone.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a fastener and stylet in accordance witha first embodiment of the present disclosure;

FIG. 2 is an enlarged perspective view of the distal end of the fastenerof FIG. 1 ;

FIGS. 3 and 4 are enlarged perspective views of an alternativeembodiment according to another embodiment of the present disclosure;

FIG. 5 is a perspective view of a fastener in accordance with anotherembodiment of the present disclosure;

FIG. 6 is an enlarged perspective view of the distal end of the fastenerof FIG. 5 ;

FIG. 7 is a perspective view of a fastener and stylet in accordance withanother aspect of the present disclosure;

FIG. 8 is an enlarged view of the distal end of the fastener of FIG. 7 ;

FIG. 9 is a perspective view of a fastener and stylet in accordance withyet another aspect of the present disclosure;

FIG. 10 is an enlarged view of the distal end of the fastener of FIG. 9;

FIG. 11 is a cross-sectional view of the proximal end of the fastener inconjunction with the Stylet of FIG. 9 ;

FIG. 12 is a perspective view of another fastener in conjunction with astylet according to another embodiment of the present disclosure;

FIG. 13 is an enlarged perspective view of the distal end of thefastener of FIG. 12 ;

FIG. 14 is an enlarged view of a distal end of an alternative fasteneraccording to another embodiment of the present disclosure;

FIG. 15 is a perspective view of a fastener according to yet anotherembodiment of the present disclosure;

FIG. 16 is an enlarged view of the distal end of the fastener of FIG. 15;

FIGS. 17-21 are enlarged perspective views of the distal ends offasteners according to various alternative embodiments of the presentdisclosure;

FIGS. 22-23 are schematic representations of the fastener of FIG. 3during implantation into a pedicle bone;

FIGS. 24-27 are schematic representations of the fastener of FIG. 1during implantation into a pedicle bone;

FIG. 28 is a schematic view of an advancement device in conjunction witha robotic end effector in accordance with an aspect of the presentdisclosure;

FIG. 29 is a cross-sectional view of the advancement device of FIG. 28 ;

FIG. 30 is a perspective view of a placement device according to anotherembodiment of the present disclosure;

FIG. 31 is an enlarged view of a drive mechanism of the placement deviceof FIG. 30 ;

FIG. 32 is an exploded view of the placement device of FIG. 30 ;

FIGS. 33 and 34 are cross-sectional views of the placement device ofFIG. 30 ;

FIG. 35 is a side view of the placement device of FIG. 30 ;

FIG. 36 is a perspective side view of the driving gear of the placementdevice of FIG. 30 ;

FIG. 37 is a side view of the double drive mechanism of the placementdevice of FIG. 30 ; and

FIGS. 38-41 are schematic representations of the placement device ofFIG. 30 in conjunction with a stylet and a screw;

FIG. 42 is a perspective side view of a stylet control system accordingto an embodiment of the present disclosure;

FIG. 43 is an exploded view of the stylet control system of FIG. 42 ;

FIG. 44 is an enlarged view of the exploded view of the proximal end ofthe stylet control system of FIG. 43 ;

FIG. 45 is a cross-sectional view of a quick connect feature of thestylet control system of FIG. 42 ;

FIG. 46 is a perspective side view of the proximal end of thescrewdriver of the stylet control system of FIG. 42 ;

FIG. 47 is a cross-sectional view of the control device of the styletcontrol system of FIG. 42 ; and

FIG. 48 is a perspective side view of a robotically operative styletcontrol system in conjunction with a robotic device according to anaspect of the present disclosure;

FIGS. 49-53 are perspective side views of a robotically operative styletcontrol system in conjunction with a robotic device according to anaspect of the present disclosure;

FIG. 54 is a cross-sectional view of the control system of FIGS. 49-53 ;

FIG. 55 is a perspective side view of an ultrasonic stylet controldevice in conjunction with a robotic device according to an aspect ofthe present disclosure;

FIG. 56 is a cross-sectional view of the control device of FIG. 55 ;

FIG. 57 is a cross-sectional view of the stylet and bone screw of thesystem of FIG. 55 at the bone interface;

FIG. 58 is a perspective side view of a cannulated drill for use inconjunction with the control device of FIG. 55 ;

FIG. 59 is a perspective side view of a robotically operative styletcontrol device in conjunction with a ultrasonic transducer;

FIG. 60 is a perspective view of a fastener in accordance with anotheraspect of the present disclosure;

FIG. 61 is an enlarged view of the distal end of the fastener of FIG. 60;

FIG. 62 is a perspective view of a fastener in accordance with anotheraspect of the present disclosure;

FIG. 63 is an enlarged view of the distal end of the fastener of FIG. 62;

FIG. 64 is a perspective view of a fastener in accordance with anotheraspect of the present disclosure;

FIG. 65 is an enlarged view of the distal end of the fastener of FIG. 64;

FIG. 66 is a perspective view of a fastener in accordance with anotheraspect of the present disclosure;

FIG. 67 is an enlarged view of the distal end of the fastener of FIG. 66;

FIG. 68 is a perspective view of a fastener in accordance with anotheraspect of the present disclosure;

FIG. 69 is an enlarged view of a distal end of a fastener according toanother aspect of the present disclosure; and

FIG. 70 is a perspective view of a fastener in accordance with anotheraspect of the present disclosure.

DETAILED DESCRIPTION

The present invention generally relates to a fastener to be used inconjunction with spinal rods during spinal surgery. Those of skill inthe art will recognize that the following description is merelyillustrative of the principles of the invention, which may be applied invarious ways to provide many different alternative embodiments.

The various embodiments of the bone screws or fasteners described beloware designed to facilitate efficient and accurate screw insertion duringsurgery. In some embodiments, the fasteners are cannulated for receivinga stylet extending through the length of the channel. In such cases, thestylet includes a sharp tip to create a pilot hole. In otherembodiments, certain fasteners are solid along the shaft rather thanbeing cannulated. In such embodiments, the distal tip of the shaft ofthe fastener includes a sharp cutting tip for forming a pilot hole anddrilling into the bone. The use of the fasteners and/or stylet forcreating the pilot hole and cutting into the bone until the threads ofthe fasteners engage and pull the screw into the bone eliminates thesteps of reaming, awling, tapping the hole, or otherwise preparing thehole, before the screw can be placed into the prepared hole. As aresult, the fasteners in the present disclosure provide for moreefficient implantation.

FIGS. 1-2 depict a first embodiment of a fastener 100 and a Kirschnerwire or stylet 150 that is configured for spinal applications, and inparticular, for the use of fastener 100 as a pedicle screw, as will bedescribed in detail below. Fastener 100 includes a screw shaft 103 and atulip 104, which has a channel adapted to receive a spinal rod. A spinalrod can be installed into tulip 104 and held in place by a set screw(not shown), which can be threaded into internal threads of tulip 104.

Fastener 100 is polyaxial in that shaft 103 is separate from andpolyaxially movable with respect to tulip 104. Tulip 104 and a proximalend 107 of shaft 103 can generally be referred to as a head of fastener100. Shaft 103 extends along a longitudinal axis from its proximal end107 to a distal tip 109. Proximal end 107 of shaft 103 forms aninterference fit connection with a distal opening of tulip 104 to createthe polyaxial connection. Tulip 104 can swivel to form different angleswith respect to shaft 103 which allows for proper rod placement. Inalternative embodiments, the fastener may be a monolithic structure withthe tulip statically connected with the proximal end of shaft 103.

Shaft 103 includes threads 112 extending between proximal end 107 anddistal tip 109. As seen in FIGS. 1 and 2 , fastener 100, including shaft103 and tulip 104, is cannulated through its entire length for receivingstylet 150 as shown. Stylet 150 terminates at a sharp distal point 156.

With reference to FIG. 2 , distal tip 109 of shaft 103 is an annularsurface that includes at least one cutting edge 115 for cutting into thecortical bone and facilitating initial engagement with the bone duringinsertion of fastener 100 such that distal tip 109 may be referred to asa drill tip. Cutting edges 115 are shaped to propagate a hole in thebone during advancement of fastener 100. The annular surface of distaltip 109 forms two flat surfaces between cutting edges 115 in the form ofnotches for cutting the bone.

Threads 112 extend along shaft 103 to a distal end 112 a adjacent thedistal tip 109 and cutting edges 115. With the placement of thread 112in close proximity to the cutting edges 115, the threading facilitatesthe pulling motion of fastener 100 into the bone immediately aftercutting edges penetrate cortical bone.

The embodiment of fastener 100 shown in FIGS. 1 and 2 includes a doublelead thread. With a double lead thread, there are, as shown, two cuttingedges 115. Other embodiments may include a single or a triple leadthread, or may include more threads around shaft 103. For example, FIGS.3 and 4 show a fastener 100′ which is substantially similar to fastener100 except that the threading includes a triple lead thread, andfastener 100′ includes three cutting edges 115′ at distal tip 109′ forcutting into the cortical bone until threads 112′ engage the bone andpull fastener 100′ into placement. The cutting edges 115′ are formed bythe thread exiting the bottom of the screw tip. A triple lead threadadvantageously provides a more balanced approach that prevents grabbingof the bone by only one of the cutting edges. The number of cuttingedges 115 does not have to equal the number of threads 112 along shaft103, since the function of cutting edges 115 to penetrate the bone isnot always aligned with the function of threads 112 to advance fastener100 along its trajectory within the bone.

FIGS. 5 and 6 depict a fastener 200 according to another embodiment ofthe present disclosure. Fastener 200 differs from fastener 100 in thatshaft 203 is not cannulated but rather includes a cutting drill point216 at the distal end 209 of the shaft. Threads 212 transition into thecutting point 216 at distal end 209, such that cutting point 216 formsthe drill tip to cut into the bone to form the hole without the use of astylet. The distal portion of the shaft 203 may include one or moreflutes 214. Fastener 200 is polyaxial, though it can also be constructedas a monoaxial embodiment.

The fasteners of FIGS. 3-6 include a smooth transition region betweenthe cutting features and the threads. The smooth transition regionallows the cutting features to continuously cut into bone until thecutting blends into the threads, which create the axial force to pushthe threads forward into the bone. In FIG. 4 the geometry is similar toan end mill, and in FIG. 5 the geometry is similar to a brad point drilltip.

As a result of cutting drill point 216, fastener 200 can be insertedinto the bone in one step which eliminates a separate step of reaming ordrilling the hole with a separate tool before inserting fastener 200into the bone. This advantageously reduces the number of steps and toolsrequired during surgery. Additionally, the sharp cutting point 216facilitates accuracy of the placement of the bone screw during insertionbecause it can be pushed into the bone to penetrate slightly and dockfastener 200 to prevent skiving during insertion.

FIGS. 7 and 8 depict a fastener 300 similar to fasteners 100 and 200.Like fastener 100, fastener 300 is cannulated for receiving stylet 350.Fastener 300 includes distal end 309 formed into a drill point 316 withtwo cutting edges 315. Drill point 316 is sized and configured to cutinto the bone to form the hole during insertion of fastener 300 into apedicle. As with fastener 100, stylet 350 can be pushed into the bone toprevent skiving of fastener 300 during insertion.

Another embodiment of the present disclosure is a fastener 400, shown inFIGS. 9-11 . Fastener 400 includes channel 415 extending through theentirety of the shaft 403 for receiving stylet 450.

Stylet 450 includes elongated shaft body 452 extending along alongitudinal axis and terminating at sharp distal tip 456. Body 452 ofstylet 450 extends through a proximal end of the shaft 403 and out ofdistal end 409 such that the sharp tip 456 of stylet 450 extends beyondthe distal end 409 of the shaft 403 of fastener 400.

Body 452 of stylet 450 includes a keyed stop 458 that is engageable witha corresponding stop member, ledge, or shoulder positioned on or near aproximal end of shaft 403. In an engaged position, the stylet isrotationally and axially fixed with respect to shaft 403 of fastener400. Stylet 450 can be disengaged from the locked relationship betweenthe stylet and the shaft 403 so that the stylet can be removed from thecannulated channel of the fastener. Alternatively, stylet 450 may befrangibly connected to the screw, such that the frangible connection canbe fractured for removal of the stylet after the bone screw is insertedinto bone.

Keyed stop 458 may be in the form of a flat section running along atleast a length of body 452 of stylet 450 to ensure that the body remainsin an axially-fixed and rotatably-fixed position relative to shaft 403.The cross-section of stylet 450 is non-circular to include the flatsection or to be hexagonally shaped so that it can be rotationallylocked with the internal lumen of fastener 400. Thus, once stylet 450 isin place, the tip 456 coupled with distal end 409 of fastener 400 isconfigured similarly to cutting point 216 of non-cannulated fastener200.

During use, stylet 450 is first positioned within channel 415 of shaft403 such that the keyed stop is engaged and the stylet is axially androtationally fixed relative to the shaft. With the stylet 450 secured tothe shaft 403, the sharp tip 456 of the stylet 450 extends furtherdistally than the fastener to form the cutting point. With stylet 450secured to shaft 403, distal end 409 of fastener 400 has the same shapeand geometry of fastener 200. Fastener 400 and stylet 450 rotatesimultaneously as the fastener and stylet are advanced into bone. Afterfastener 400 is implanted to the desired depth in the bone, the keyedstop is disengaged and stylet 450 can be removed from the fastener. Theremoval of stylet 450 may be advantageous in certain instances becausethe sharp point 456 of the stylet is removed from the anatomy which mayresult in less damage to the surround area over time.

FIGS. 12 and 13 depict a fastener 500 according to yet anotherembodiment of the present disclosure. Fastener 500 incudes a cannulatedthreaded shaft 503 that terminates at distal tip 509. Distal tip 509includes saw tooth members 540 positioned around the circumferencethereof. Each saw tooth member 540 is in the shape of a triangularmember terminating in a point. In the illustrated embodiment, there aresix saw tooth members 540; however, in other embodiments there may bemore or less of the saw tooth members positioned around thecircumference of the distal tip. Additionally, the saw tooth members maybe larger or smaller depending on the number of members around thecircumference. Although shown as triangularly shaped, in other examples,the saw tooth members may be trapezoidal, rectangular, etc.

FIG. 14 depicts a fastener 600 according to another embodiment of thepresent disclosure. Fastener 600 includes cannulated shaft that includesthread having serrations 634 along a portion of the shaft. Serrations634 include alternating peaks and valleys. Serrations 634 may be in theform of the various embodiments of serrations described in U.S.application Ser. No. 15/645,264 filed on Jul. 10, 2017 and titled SpinalFastener with Serrated Thread. The inclusion of the serrations reducesinsertion torque, which reduces the chance of bone fracture andbreaching. The shaft terminates at distal tip 609 which includes sharptriangular-shaped saw tooth members 640 positioned around thecircumference of the distal tip.

FIGS. 60-61 show a fastener 1300 according to another embodiment of thepresent disclosure. Fastener 1300 includes cannulated shaft 1303 that isthreaded along its length to distal tip 1309. Shaft 1303 tapers towarddistal tip 1309, and distal tip 1309 includes substantially V-shaped sawtooth members 1340 positioned around the circumference of the distal tip1309, as best shown in FIG. 61 .

FIGS. 62-63 show fastener 1400 according to another embodiment of thepresent disclosure. Fastener 1400 is similar in most respects tofastener 1300 except that shaft 1403 has a constant major diameter.

FIGS. 64-65 show fastener 1500 according to another embodiment of thepresent disclosure. Fastener 1500 includes cannulated shaft 1503 whichtapers to distal tip 1509. Fastener 1500 includes substantially C-shapedsaw tooth members 1540 such that between adjacent tooth members is acurved edge rather than the pointed edge shown in FIG. 61 in connectionwith fastener 1300. FIGS. 66-67 show fastener 1600 according anembodiment that is substantially identical to fastener 1500 except thatfastener 1600 includes shaft 1603 with major constant diameter ratherthan a tapering profile, as in fastener 1500. FIG. 68 shows fastener1700 which is another variant of fasteners 1500 and 1600, with fastener1700 including shaft 1703 with a constant major diameter and taperingminor diameter. FIG. 69 shows the distal tip of fastener 1800, which isanother variant to fastener 1500. Fastener 1800 includes saw toothmembers 1840 angled relative to one another.

FIG. 70 shows fastener 1900 according to another embodiment of thepresent disclosure. Fastener 1900 includes cannulated threaded shaft1903 which terminates at distal tip 1909. Distal tip 1909 includes aonly single cutting member 1940 for cutting into the bone. The singlecutting member 1940 may have a rectangular, trapezoidal, triangular, orc-shape.

Referring to FIGS. 15 and 16 , a fastener 700 includes a non-cannulatedthreaded shaft 703 terminating at rounded distal tip 709 that includesburr members 722 that allow for high speed cutting of the cortical bone.The burr members 722 are positioned around the circumference of thedistal tip and are separated from one another by cut-out portions.

In another embodiment, shown in FIG. 17 , a fastener 800 includes aself-drilling distal tip 809 with one or more flutes 828 positioned at adistal portion of shaft 803. Threading 812 extends to the distal tip 809which allows the shaft to engage and anchor into the bone immediatelyupon contact.

In an alternative embodiment, shown in FIG. 18 , a fastener 900 includesself-drilling distal tip 909 of the shaft which includes a helicallythreaded portion 932. The pitch of threaded portion 932 is less thanthat of threads 912 of the shaft. As shown in the illustratedembodiment, the distal end of the shaft may include one or more flutesthat do not cut across the entire helically threaded portion 932.

In yet another embodiment, FIG. 19 shows a fastener 1000 having a distaltip that includes first threaded portion 1014 and second unthreadedportion 1016 which tapers inwardly to form a pointed tip 1009 tofacilitate a self-drilling tip. The shaft also includes a cutting fluteextending to pointed tip 1009.

FIG. 20 shows a fastener 1100 which includes a threaded portion 1112adjacent a distal portion of the shaft that has tap threads 1132. Tapthreads 1132 extend along less than half of the length of the shaft andmay extend along about one-third of the length of the shaft. Tap threads1132 are of a smaller pitch than the threads of threaded portion 1112,and also include a helical flute extending along tap threads 1132 tofacilitate threading of the hole through the cortical bone.

In another embodiment, shown in FIG. 21 , a fastener 1200 includes ashaft that terminates at awl tip 1209. Awl tip 1209 is configured tocreate the pilot hole during implantation of fastener 1200. Threads 1212may overlap a portion of the awl tip or, as shown, threads 1212 mayterminate at the proximal-most end of the awl tip.

It is contemplated that each of the non-cannulated fasteners canalternatively be cannulated for use with a stylet.

The method of using the solid, non-cannulated fasteners (i.e. fasteners200, 700, 800, 900, 1000, 1100, 1200) will now be described withspecific reference to fastener 200, although the method applies to eachof the aforementioned non-cannulated fasteners. As shown in FIG. 22 ,fastener 200 is positioned on the pedicle bone and distal tip 209 isdocked onto the bone. The fastener 200 is pushed into the bone until thedistal tip penetrates the bone to dock the fastener. This allows for anaccurate point of entry during initial insertion of the fastener intothe bone and prevents skiving of the screw. Torque is applied to thefastener, either by manual insertion, robotic or power insertion. Thedistal tip 209 cuts the bone until threads 212 catch bone and advancethe screw into the bone, shown in FIG. 23 .

A similar method of implantation is used with fastener 400 as the stylet450 and fastener become “integral” with one another while stylet 450 isin the engaged position and axially and rotationally locked with respectto fastener 400. After implantation of fastener 400, stylet 450 isremoved from the bone.

The method of using the cannulated fasteners (i.e. fasteners 100, 300,500, 600) will now be described with specific reference to fastener 100,although the method applies to each of the aforementioned cannulatedfasteners. As shown in FIG. 24 , stylet 150 is positioned within thechannel of the shaft 103 of fastener 100. Sharp tip 156 of stylet 150 isused to form the pilot hole. The stylet is then advanced into the bone,while shaft 103 remains placed on or above the bone surface. The styletis advanced into bone about 5 to 30 millimeters, as shown in FIG. 25 .Torsion is applied to fastener 100 such that the screw rotates withrespect to stylet 150, which remains at its same depth within the boneduring insertion of fastener 100, and the cutting feature of the distalend of fastener 100 cuts into the cortical bone. For fastener 100, thecutting feature includes cutting edges 115. As fastener 100 cuts intobone, stylet 150 remains axially fixed and does not advance farther intothe bone. The securement of stylet 150 in the bone at the desired depthof screw placement while fastener 100 is being advanced into the bonehelps to prevent skiving. The advancement of fastener 100 relative tothe secured stylet 150 helps to maintain the accurate trajectory of thefastener. Fastener 100 is advanced to the desired depth by continuing torotate fastener 100 until its threads engage the bone and advancefastener 100 down stylet 150, as shown in FIG. 26 . The depth to whichfastener 100 is inserted is just smaller than the depth to which stylet150 has been inserted. After final placement of the fastener, stylet 150is pulled proximally and removed from the shaft of fastener 100, asshown in FIG. 27 . Removal of the sharp tip of stylet 150 isadvantageous in that it prevents damage that could otherwise be causedby the sharp feature to the surrounding area after the procedure.

The use of the stylet to maintain the proper trajectory during screwplacement is advantageous particularly in instances where a fastener isscrewed into a first surface of a first bone, is passed out of a secondsurface of the first bone, is made to traverse a gap between bonesegments, and is screwed into a second bone segment. Typically, withoutthe use of a stylet, as the screw exits the first bone and traverses thegap, the screw's path loses its accuracy before entering the secondbone. In the present disclosure, the movement of the screw over thepreviously positioned and secured stylet maintains the placement of thescrew along the proper position of the second bone despite having totraverse a gap. This technique is particularly useful in surgeriesinvolving smaller pedicles, such as the pedicles of the thoracic spine.Placement of the stylet through the bone portions across the gap doesnot present the same difficulties, particularly given its sharp tip andthe fact that it can be pushed or oscillated during insertion as opposedto being rotated. Often the skiving of a bone screw occurs based on thetip of the screw moving along the bone surface as it attempts topenetrate the surface while it is rotating. The fasteners of the presentinvention are aimed at eliminating this problem.

The step of advancing the stylet into the bone can be performed with theuse of a robotic end effector 2000 and an advancement mechanism 2100positioned at a proximal end of robotic end effector 2000. In theillustrated embodiment, shown in FIGS. 28 and 29 , advancement mechanism2100 includes threaded knob 2105 which engages the stylet as threadedknob 2105 is rotated in a first direction. As threaded knob 2105 isadvanced distally, the stylet translates distally through a screwdriver2200 and through the cannulated channel of the attached fastener. Thestylet is connected to a sliding coupler 2107 that travels axiallywithin the advancement mechanism. The coupler is attached to the styletvia a set screw to secure the stylet to the coupler. Once the stylet isadvanced to the desired depth, threaded knob 2105 can be disengaged fromthe stylet and removed such that the stylet remains secured within thebone while the fastener is then rotated to advance the fastener into thebone. In alternative embodiments, advancement mechanism 2100 can includea spring, cam or gear in place of the threading to advance the styletdistally through screwdriver 2000 and the attached fastener.

FIGS. 30-37 show a placement device 3100 that may be used to place astylet and fastener into the bone. Placement device 3100 may be usedwith robotic end effector 2000 or may be used during manual insertion.Placement device 3100 allows the stylet to oscillate back and forthbetween clockwise and counter clockwise directions while the fastener isadvanced over the stylet in just one of those rotational directions andthreaded into bone.

Placement device 3100 includes a drill adaptor 3130 through which themotor of end effector 2000 can be connected to device 3100. Drilladaptor 3130 communicates with a double drive mechanism 3120, as bestshown in FIGS. 31, 32, and 37 . Double drive mechanism 3120 includesgear system 3125 formed of a driving gear 3129 and a driven gear 3127.Driving gear 3129 has a splined outer surface at its proximal end thatmates with a complimentary splined internal surface (not shown) of thedrill adaptor 3130 so that rotation of drill adaptor 3130 is translatedinto rotation of driving gear 3129. Driving gear 3129 is connected todriven gear 3127 through two connector gears 3131, 3132 disposed atopposite sides of a collar 3133. Through this connection, rotationalmovement of driving gear 3129 in one direction, e.g. clockwise,corresponds to rotational movement of driven gear 3127 in the oppositedirection, e.g. counter clockwise.

A housing 3134 is disposed within the circumferences of driving gear3129, driven gear 3127, and collar 3133. Housing 3134 has two recesses3135, 3137 in which ratcheted pawls 3136, 3138, respectively, aredisposed, as shown in FIG. 37 . In FIG. 37 , driven gear 3127 is shownin a misaligned state so that pawl 3136 is exposed, and driving gear3129 is removed to expose pawl 3138. As shown in FIG. 36 , an internalcircumferential surface 3139 of driving gear 3129 is splined forcommunication with the ratcheted outer surface of pawl 3138. An internalcircumferential surface (not shown) of driven gear 3127 is similarlysplined for communication with the ratcheted outer surface of pawl 3136.Both of pawls 3136, 3138 are ratcheted in the same direction about theaxis of device 3100. When one gear is in ratcheted connection with itspawl, the other gear slips past its pawl, and vice versa.

Pawl 3136 is connectable to a screw driver shaft 3141 through a pin3142. Similarly, pawl 3138 is connectable to screw driver shaft 3141through a pin 3143. Since pawls 3136, 3138 are both ratcheted in thesame direction while gears 3127, 3129 disposed circumferentially abovethem are connected in opposite rotational directions, this dictates thatrotational motion of housing 3134 will always only be driven by one ofgears 3127, 3129 through its respective pawl 3136, 3138. That is, whendriving gear 3129 is rotated in a direction to engage with pawl 3138,pawl 3138 engages screw driver shaft 3141 so that housing 3134 isrotationally locked with screw driver shaft 3141. Also, when driven gear3127 is rotated in a direction to engage with pawl 3136, pawl 3136engages screw driver shaft 3141 so that housing 3134 is rotationallylocked with screw driver shaft 3141. The opposite rotational directionsof gears 3127, 3129 therefore dictate that screw driver shaft 3141 willalways be rotationally locked with housing 3134 and that housing 3134will always be rotated in the same direction regardless of the directionin which drill adaptor 3130 is rotated.

Based on the structural makeup of device 3100 as described above,rotation of drill adaptor 3130 in either direction (i.e. clockwise orcounter clockwise) will result in rotation of screw driver shaft 3141 ina single direction (i.e. only clockwise or only counter clockwise). Asdevice 3100 is configured for insertion of a fastener, the directionscrew driver shaft 3141 rotates is clockwise by right-hand rule. Adistal end of screw driver shaft 3141 is noncircular to mate with thetulip of the fastener to facilitate insertion. A screw driver sleeve3144 is disposed about screw driver shaft 3141 such that screw drivershaft 3141 can rotate therein. A distal end of screw driver sleeve 3144has an annular depression in which interior flanges of each prong of thetulip can be seated to maintain the fastener at the end of device 3100,particularly as it is advanced toward the surgical site.

The operation of gear system 3125 is made possible because an outerhousing 3145 is held stationary (i.e. non rotatable) during operation ofdevice 3100. Outer housing 3145 is either held by the user or connectedto the end effector 2200 during operation. Pins 3146, 3147 are anchoredto outer housing 3145, through connector gears 3131, 3132, respectively,and into collar 3133. This allows drill adaptor 3130 to be rotationallyconnected to driving gear 3129 and driven gear 3127, and ultimately tohousing 3134 to drive screw driver shaft 3141, which in turn drives thefastener.

Another simultaneous function of driver 3100 is that it can rotate astylet 3180 through a threaded proximal end 3181 of stylet 3180. Athreaded internal surface 3182 of housing 3134 is threadedly connectedwith threaded proximal end 3181. Also, a pin 3149 is disposed throughhousing an aperture in threaded proximal end 3181 and protrudes througha slot in drill adaptor 3130 at either end, so that rotation of drilladaptor 3130 in one direction (i.e. clockwise or counter clockwise)always corresponds with rotation of stylet 3180 in the same direction(i.e. clockwise or counter clockwise, respectively) as drill adaptor3130. Thus, when drill adaptor 3130 is oscillated, stylet 3180 is alsooscillated. When drill adaptor 3130 is rotated in one direction, stylet3180 is rotated along with it.

The threaded connection of stylet 3180 with housing 3134 adds a furtheruseful dimension to device 3100 since housing 3134 is axially stationaryalong device 3100 though it rotates in one direction due to double drivemechanism 3125. Assuming device 3100 is configured so that clockwiserotation by right-hand rule advances the fastener distally, duringclockwise rotation of drill adaptor 3130, torque is transmitted by theslot in drill adaptor 3130 via pin 3149 to stylet 3180, and stylet 3180is simply driven in the same clockwise direction, though no translationof stylet 3180 occurs. The threads of threaded proximal end 3181 andhousing 3134 are of the same pitch. When stylet 3180 and housing 3134both rotate in the same direction, there is no relative movement betweentheir threads. When the input motion is reversed to counter clockwiserotation of drill adaptor 3130, stylet 3180 once again follows in thesame counter clockwise direction of drill adaptor 3130, but since it isthreaded to housing 3134 that is rotating in the opposite clockwisedirection, the relative motion between the mating threads causes anaxial translation of stylet 3180, having the effect of incrementalretraction. The slot in drill housing 3130 through which pin 3149 isdisposed accommodates translation of stylet 3180. The position of thepin 3149 along the length of the slot can serve as an indicator forwhere the tip of stylet 3180 is relative to the tip of the fastener, andcould include depth markings to give a more precise indication.Selecting a particular pitch and lead of threads dictates how much axialtranslation occurs for a given angular rotation of drill housing 3130.Additionally selecting a particular pitch and lead of thread on thefastener dictates how much relative axial translation occurs between thebone and stylet 3180.

Any of the previously described rotations or translations could bereversed to achieve alternative surgical goals, such as progressivelyadvancing stylet 3180 or maintaining a constant stylet 3180 depthrelative to the bone. A simple switch can also be provided to allow theuser to mechanically select between “forward” (as described above) and“reverse” modes of device 3100.

Spine surgeons currently use a natural oscillating motion to advanceinstruments into the spine to create a pilot hole in the pedicle toprepare for screw insertion. For example, a surgeon will twist an awl,gearshift, or jamshidi needle back and forth to carefully advance it tothe desired depth. While device 3100 can be utilized eitherelectronically (via power or a robot) or manually by hand, it capturesthis desired oscillating motion while simultaneously driving thefastener over the stylet in a single, efficient tool.

During use of device 3100, stylet 3180 is first loaded by setting it tothe proper depth relative to the length of the intended fastener. Sincedevice 3100 is configured to either maintain the axial position ofstylet 3180 or retract it, this is the furthest distally that the tip ofstylet 3180 will be positioned relative to the handle of device 3100during the procedure. A fastener 3300 is then loaded onto device 3100 byplacing it over stylet 3100 and connecting it to screw driver shaft3141. Device 3100 is advanced until the distal tip of stylet 3100 isdocked to the bone, as shown in FIG. 38 . At this point or duringdocking, the surgeon can begin to oscillate drill housing 3130 by handor robotically by keeping outer housing 3145 stationary and not rotatingit. This oscillating motion of stylet 3180 during docking preventstugging on the local tissue and tendons so that the procedure can becarried out most efficiently and with the least disruption to thesurrounding anatomy. While this practice is currently used by surgeons,the oscillation of stylet 3180 even when device 3100 is used roboticallyprovides surgeons with comfort that the same technique is being appliedduring the procedure.

Continued oscillation of drill housing 3130 while device 3100 is beingpushed distally embeds the tip of stylet 3180 into the bone untilfastener 3300 meets the bone surface. At this point, further oscillationof drill housing 3130 engages the threads of fastener 3300 into the boneto advance fastener 3300, all while fastener is guided by the path setby stylet 3180. Upon each small counter clockwise rotation of drillhousing 3130, stylet 3180 retracts along the length of fastener 3300 sothat stylet 3180 is retracted simultaneously. In this way, the surgeoncan cannulate the pedicle via oscillating rotational motion of a sharpcutting tool such as a stylet or stylet 3180, while simultaneouslyadvancing a cannulated screw or fastener 3300 over stylet 3180, alldriven by a single oscillating input motion to device 3100.

In other embodiments similar to device 3100, the threaded connection andautomatic retraction of stylet 3180 can be omitted and stylet 3180 cansimply be pulled from the surgical site once fastener 3300 is implantedto the appropriate depth.

According to another embodiment of the present disclosure, FIGS. 42-47show a stylet control system 4000 for selective and controlled axialmovement (i.e. advancement and/or retraction) of a stylet for use duringsurgery in which a cannulated bone screw is inserted into bone aroundthe stylet. Stylet control system 4000 includes control device 4120 foruse in conjunction with a threaded stylet 4150 and a screwdriver 4170during a spinal surgery in which a pedicle screw 4010 is implanted inbone. Control device 4120 may be controlled manually or with a roboticdevice, such as a robotic end effector.

Bone screw 4010 includes a head portion, a threaded shaft 4011, and atulip 4020 for coupling the screw to an orthopedic rod. Bone screw 4010may be a standard size pedicle screw or it may be a screw adapted foruse in minimally invasive surgery. Any of the above-described screws aresuitable for use in stylet control system 4000. Bone screw 4010 iscannulated such that stylet 4150 can extend through the cannulation andcan extend beyond a distal tip of the screw. Bone screw 4010 has athreaded shaft 4011 and its head is received within tulip 4020. Tulip4020 is designed to receive a stabilizing rod therethrough. An innersurface of tulip 4020 includes threads capable of engaging with thescrewdriver 4170, described in further detail below. Further, bone screw4010 includes a self-cutting feature at its distal end, such as sharpcutting edges.

Stylet 4150 extends between proximal end 4152 and distal end 4158, whichterminates at a sharp distal point to allow the stylet to cut throughbone to form a cannulation for ease of insertion of bone screw 4010, asdescribed above. At proximal end 4152, stylet 4150 includes monolithicthreaded portion 4159 that facilitates axial translation of the styletrelative to screwdriver 4170 and control device 4120. Stylet 4150 alsoincludes an anti-rotation feature to prevent relative rotation betweenstylet 4150 and screwdriver 4170. For example, in the illustratedembodiment, stylet 4150 includes keyed hex portion 4153 that has ahexagonal cross section extending along a portion of its length whichcorresponds to a hex feature on screwdriver 4170, described below. Asshown in FIG. 43 , hex portion extends from a distal end of threadedportion 4159. Although described herein as a hex, the mechanically keyedfeature may be square, oval, triangular, trapezoidal etc.

Control device 4120 includes proximal assembly 4121 that is rotatablerelative to screwdriver 4170. Proximal assembly 4121 includes inner core4125, coupling member 4132, and outer handle 4140. Inner core 4125defines central lumen 4126 extending therethrough for receiving stylet4150. As shown in FIG. 44 , control device 4120 includes coupling member4132 with base 4134 having a generally cylindrical shape and top portion4135 having a planar surface and a sidewall with opposing cut-outs 4135for receiving screws 4138, which secure base 4134 to inner core 4125.Base 4134 is sized to fit within central lumen 4126 of inner core 4125.Coupling member 4132 includes a threaded opening 4136 extending throughbase 4134 and top portion 4135 for engaging threaded portion 4159 ofstylet 4150.

Inner core 4125 includes an attachment feature to attach coupling member4132 to proximal end 4130 of inner core 4125. In the illustratedembodiment, the attachment feature is in the form of two threaded bores4128 extending into proximal end 4130 of inner core 4125 that are sizedfor receiving set screws 4138. With coupling member 4132 axially androtationally secured to inner core 4125, threaded opening 4136 of thecoupling member is coaxial with central lumen 4126 of the inner core sothat stylet 4150 can extend through the assembly. In other examples,coupling member 4132 may be integral or monolithic with inner core 4125.

Control device 4120 also includes outer handle 4140 housing couplingmember 4132 and inner core 4125. Outer handle 4140 defines central lumen4146 extending longitudinally through its entirety. Central lumen 4146is sized to accommodate inner core 4125. Outer handle 4140 has a roundedouter surface to allow for a user to comfortably grip the handle. Outerhandle 4140 is axially and rotatably fixed to inner core 4125 andcoupling member 4132 such that when the outer handle 4140 is rotated ina first direction, e g manually or robotically, inner core 4125 andcoupling member 4132 are also rotated in the first direction. In theillustrated embodiment shown in FIG. 46 , a proximal end of couplingmember 4132 extends farther proximally than the proximal end of outerhandle 4140, such that threaded opening 4136 is positioned proximal toouter handle 4140. Further, when stylet 4150 is positioned within innercore 4125, a portion of stylet 4150 extends proximally to outer handle4140 as shown in FIG. 42 .

Control device 4120 includes quick connect system 4141 that facilitatesa simple and efficient connection to the proximal end of screwdriver4170, as shown in detail in FIGS. 45-47 . Quick connect system 4141includes a collar 4144 that surrounds a distal shaft 4127 of inner core4125. An inner shaft 4180 of screwdriver 4170 is connected to collar4144 via at least one a spring-loaded ball bearing 4148 received withina radial groove 4178 on inner shaft 4180 of screwdriver 4170. Whencollar 4144 is located radially outside of radial groove 4178 with theball bearing disposed within the groove 4178, collar 4144 does notpermit the ball bearing 4148 to leave groove 4178, thereby connectingcontrol device 4120 and screwdriver 4170. The engagement of ball bearing4148 and groove 4178 prevents axially movement of control device 4120relative to screwdriver 4170 but allows rotation of the control device4120 relative to the screwdriver 4170. When collar 4144 is moved away,the ball bearing can move radially outward so that control device 4120and screwdriver 4170 can be disconnected. Screwdriver 4170 also includesrecess 4176 for attaching an alternative quick connect in the event theuser wants to use a standard handle to manually drive the screw intobone.

The quick connect system 4141 may be released by applying an axial forcein the proximal direction, which may be applied by a user to collarflange 4149, to remove the radial load applied against the screwdriver4170 to disengage the screwdriver from the control device 4120.

Referring to FIGS. 42 and 43 , screwdriver 4170 extends between proximalend 4172 and distal end 4184. Distal end 4184 is configured for securingto and engaging a screw, such as pedicle screw 4010. Screwdriver 4170may be used with mono-axial pedicle screws, poly-axial pedicle screws,reduction screws, or screws designed for minimally invasive surgeries(MIS screws).

At distal end 4184, screwdriver 4170 engages screw 4010. An outer sleevemay include external threaded portion configured to thread intocorresponding threads on the inner surface of the tulip 4020 of screw4010. Inner shaft 4180 is positioned concentrically within the outersleeve and includes a driving member for engagement within acorresponding opening of the head of bone screw 4010. The driving membermay be hexagonally shaped designed to torque bone screw 4010 to advancethe screw into bone. Alternatively, inner shaft 4180 may include threadsto engage the threads of tulip 4020 of screw 4010.

Inner shaft 4180 is cannulated along its length and defines inner lumen4181 to allow stylet 4150 to extend entirely through the shaft andthrough bone screw 4010. Inner shaft 4180 includes an anti-rotationfeature at its proximal end to prevent stylet 4150 from rotatingrelative to screwdriver 4170. In this manner, stylet 4150 isrotationally coupled with screwdriver 4170, and both are rotatablerelative to proximal handle assembly 4121. In the illustratedembodiment, the anti-rotation feature includes a hex-shaped innersurface 4182 surrounding inner lumen 4181 on at least the proximal endof the screwdriver 4170. Hex portion 4153 on stylet 4150 is sized andshaped to fit within inner shaft 4180 without relative rotationalmovement between the hex members 4153, 4182, thus rotationally couplingthe elements.

System 4000 is also designed for use in robot-assisted surgery and canbe connected to a robotic device to facilitate the torqueing of bonescrew 4010 into the bone and/or to facilitate the movement of stylet4150. In other examples, system 4000 can be manually operated in part,i.e. control device 4120 may be manually operated while the screwdriveris robotically operated, or both pieces can be either robotically ormanually operated. For example, as shown in FIG. 48 , a robotic device4200 including a robotic arm with a rotatable end effector coupled tothe end of the robotic arm can interface with a robotic unit couplerpositioned on proximal end 4172 of screwdriver 4170. The robotic couplerincludes at least one tab for transmitting torque to the screwdriver.End effector 4210 transmits torque to inner shaft 4180 to rotate theshaft 4180 in a clockwise direction to advance the screw in bone. Whenthe control device 4120 is held stationary during this robotic rotationof screwdriver 4170, stylet 4150 retracts proximally.

To assemble system 4000, stylet 4150 is first advanced through controldevice 4120 and threaded portion 4159 of stylet 4150 is threaded intothreaded opening 4136 of coupling member 4132. Control device 4120 isthen loaded onto screwdriver 4170 via quick connect system 4141, whilestylet 4150 is positioned through the assembled device such that itextends through the distal end of bone screw 4010. When the stylet 4150is loaded into the screwdriver 4170, stylet 4150 is rotationally fixedrelative to the screwdriver due to the mating hex features 4182, 4153 ofthe screwdriver and the stylet.

In operation, with distal end 4158 of stylet 4150 positioned againstbone, proximal handle assembly 4121 is rotated by rotating outer handle4140 in a first direction, such as in the clockwise direction. Whenouter handle 4140 is rotated in the first direction, screwdriver 4170 isheld stationary and is not rotated, which produces relative rotationalmovement between control device 4120 and screwdriver 4170. The rotationof outer handle 4140 causes inner core 4125 to rotate so that threads ofthreaded opening 4136 of inner core engage threads of threaded portion4159 of stylet 4150. Screwdriver 4170 is held stationary, meaning thatstylet 4150 is also not rotated. Thus, as threaded portions 4136, 4159engage each other, stylet 4150 advances axially through control device4120 and screwdriver 4170, i.e. stylet 4150 travels in the distaldirection, based on the threaded engagement. As stylet 4150 movesdistally it travels through bone and produces a path having the desiredtrajectory for the bone screw to follow, while the shaft of the bonescrew 4010 remains placed on or above the bone. Once stylet 4150 isadvanced to the desired depth in the bone, which may be about 5 to 30millimeters, bone screw 4010 can be implanted over stylet 4150 tomaintain the desired trajectory of the bone screw. Because bone screw4010 advances over stylet 4150, this helps to prevent skiving of the tipof bone screw 4010 relative to the intended entry point in the bone. Inthe example of robotic operation of the screwdriver 4170, the endeffector 4210 keeps the screwdriver stationary to insert stylet 4150without impaction.

It is advantageous to advance bone screw 4010 into bone without furtheradvancing stylet 4150 beyond the desired depth. In order to do so,proximal handle assembly 4121 is held stationary while screwdriver 4170is rotated in a clockwise direction. When screwdriver 4170 is rotatedclockwise, manually or robotically, inner shaft 4180 of the screwdriver4170 rotates in this direction which drives bone screw 4010 into bone.As screwdriver 4170 is rotated, and thus stylet 4150 rotates whileproximal handle assembly 4121 remains stationary, stylet 4150 travelsaxially in the retraction direction, i.e. proximally. It may beadvantageous that the pitch of the threads of the stylet are the same asthe pitch of the threads of the bone screw, which results in the styletretracting at the same rate as the bone screw is advanced.

In another embodiment according to the present disclosure, controldevice 4120 is built into the robotic end effector 4250. A back coupleris attached to end effector 4250 which functions as control device 4120and facilitates the relative rotational movement of the screwdriver 4170and the back coupler to control the movement of stylet 4150 in theproximal and distal directions, as desired. When screwdriver 4170 isdriven in the counter-clockwise direction by the end effector 4250,stylet 4150 rotates with screwdriver 4170 causing the stylet 4150 torotate relative to the back coupler. This relative rotation causesstylet 4150 to advance axially in the distal direction to advance intobone. When the end effector 4250 rotates screwdriver 4170 clockwise,stylet 4150 translates axially in the proximal direction as screwdriver4170 simultaneously drives the fastener into bone.

FIGS. 49-54 show stylet control system 7000, which is built into endeffector 7200. Control system 7000 includes cap 7027 which forms aconnection between the end effector and the instrument for use, e.g.screwdriver 7170. Cap 7027 defines passage 7029 which extends fromproximal end 7031 to distal end 7033 of cap 7027 and is sized and shapedto receive screwdriver 7170 into at least a distal portion of passage7029. Cap 7027 is configured to be attached to a proximal end of controlsystem 7000, as shown in FIG. 50 .

Screwdriver 7170, with bone screw 7010 attached to a distal end thereof,is positioned within passage 7029 and attached to cap 7027. As shown inFIGS. 49 and 50 , screwdriver 7170 extends distally from cap 7027. Cap7027 is then attached to end effector 7200 such that screwdriver 7170 isin operative engagement with the end effector. Cap 7027 may be designedas a universal cap which configured to attach to various instruments foruse during preparation of the bone and implantation of an implanttherein, e.g. screwdriver, drill, burr etc.

Control system 7000 further includes stylet 7150 which includes threadedportion 7159 at a proximal end thereof. At least a portion 7153 of thelength of stylet 7150 is keyed and screwdriver 7140 includes ananti-rotation feature, such as a corresponding keyed feature to preventrelative rotation between stylet 7150 and screwdriver 7140 whileallowing axial movement of the stylet within the screwdriver. In theillustrated embodiment, the keyed feature is shown as a hex, althoughthe mechanically keyed feature may be square, oval, triangular,trapezoidal etc. Control system 7000 includes stylet feeder 7140 sizedsuch that at least a portion of the stylet feeder 7140 is receivedwithin a proximal portion of passage 7029 of cap 7027. A portion ofstylet feeder 7140 is keyed to prevent relative rotation of the styletfeeder within cap 7027. Stylet feeder 7140 includes hinged threaded pawl7145, the threads of which are configured to facilitate one-wayengagement of threaded portion 7159 of stylet 7150, e.g. engagement tocause proximal movement of the stylet during the rotation of the stylet,while disengaging for distal advancement of the stylet. In this regard,rotation of screwdriver during advancement of bone screw 7010 into bonecauses rotation of stylet 7150 and thus engagement of threaded pawl 7145with threaded portion 7159 of stylet 7150. This engagement results inproximal movement, e.g. retraction, of stylet 7150 as the bone screw isadvanced into bone. It may be advantageous that the pitch of the threadsof the stylet are the same as the pitch of the threads of the bonescrew, which results in the stylet retracting at the same rate as thebone screw is advanced. Of course, this is not required in allembodiments and there may be some benefit to having the stylet designedto retract at a different rate.

As shown in FIG. 52 , during use, stylet 7150 is inserted into styletfeeder 7140 such that the stylet extends through screwdriver 7140 andbone screw 7010 so that the distal tip of stylet 7150 extends justbeyond the distal tip of bone screw 7010. Stylet 7150 can then beimpacted to dock the screw to the bone, such impaction can be donemanually such as by hammering or ultrasonically, such ultrasonicadvancement of the stylet is described below with reference to FIGS.55-58 . Stylet 7150 may be impacted into the bone to a depth of betweenabout 10 mm to 20 mm Once stylet 7150 is advanced to the desired depth,screwdriver 7170 is driven to advance bone screw 7010 into bone, whichcauses simultaneous retraction of stylet 7150. After stylet 7150 isadvanced to the desired depth in the bone, screwdriver 7170 is drivenvia end effector 7200 which rotates both the screwdriver and stylet7150, since the stylet is keyed to the screwdriver. As bone screw 7010is driven into bone along the trajectory defined by previously implantedstylet 7150, the threaded portion 7159 of stylet 7150 is engaged bypawls 7145, which causes proximal movement, e.g. retraction, of stylet7150 as the bone screw is advanced into bone.

According to another embodiment of the present disclosure, FIGS. 55-58show a robotic stylet control device 5000. Control device 5000 sharesmany similar to features as control device 4000 and control system 7000,described above in connection with FIGS. 42-47 and FIGS. 48-53 ,respectively, although control device 5000 is designed to facilitateultrasonic movement and oscillation of a stylet as it is advanced intobone. Control device 5000 allows for movement of a stylet through acannulated bone fastener, such as bone fasteners 100-500 and 1300-1900or a cannulated drill, shown in FIG. 58 . Control device 5000 providescontrolled axial movement (advancement and/or retraction) of a styletduring surgery including implantation of a cannulated bone fastener. Thestylet is advanced into bone to create the initial pilot hole forsubsequent insertion of the screw. Additionally, the control device 5000ultrasonically oscillates during axial movement of the stylet. Suchoscillation reduces the applied forces at the bone interface during theadvancement of the stylet, which improves robotic accuracy as itminimizes the potential of deflection of the robotic arm. The reductionof force and increased accuracy may also result in a decreasedlikelihood of skiving.

Traditionally, in during manual preparation of a site for implantationof a bone screw, the process includes multiple steps including: awling,probing, tapping and then placement of the screw. Whereas, with the useof control device 5000, the initial pilot hole is created with thestylet which is received within either a cannulated drill or acannulated bone screw. Thus, control device 5000 is advantageouslyprocedurally efficient as it eliminates the need for the traditionalsteps of pilot hole creation.

Turning to FIGS. 55 and 56 , control device 5000 includes housing 5300,retraction assembly 5140, and end effector 5200. Control device 5000further includes integrated ultrasonic transducers 5275. Housing 5300defines passage 5310 for receiving stylet 5150. Housing 5300 includes alow gain transducer assembly 5275 for imparting ultrasonic vibrations tostylet 5150. Control device 5000 further includes an energy source forgenerating the ultrasonic energy.

Transducer assembly 5275 comprises a plurality of piezoelectric elementspositioned within housing 5300. Ultrasonic vibration is induced in theend effector by electrically exciting transducers 5275. In this example,transducers 5275 are comprised of piezoelectric elements which produceultrasonic vibrations. Transducer assembly 5275 are low gain transducersand output frequencies in the range of about 10,000 Hz to about 30,000Hz. Such ultrasonic vibrations are transmitted to the stylet 5100positioned within passage 5306 of body 5300.

FIGS. 55 and 56 show control device 5000 in conjunction with screwdriver5170 and bone screw 5010 attached to the screwdriver. Stylet 5150includes threaded portion 5159 at its proximal end to facilitate theaxial movement of the stylet.

As shown in FIG. 57 , bone screw 5010 is positioned at or near the boneinterface with the distal end of stylet 5150 substantially flush withdistal end 5012 of bone screw 5010. Upon actuation of the energy sourceand thus excitation of the piezoelectric elements of transducer assembly5275, ultrasonic vibrations are induced which oscillates stylet 5150 ina reciprocating longitudinal direction in strokes of about 20 to 100micrometers (μm) which ultimately advances the stylet through distal end5012 of bone screw 5010 and within the bone to create the pilot holewhich is about 10 to 30 millimeters (mm) measured axially from theinterface of the bone. Preferably, the stylet advances about 15 mm forcreation of the pilot hole. Oscillation of stylet 5150 also occurs in areciprocating torsional direction to twist and turn the stylet while itadvances axially (shown by the arrows in FIG. 57 ).

After stylet 5150 is advanced to the desired depth, e.g. about 15 mm,stylet 5150 is simultaneously retracted via retraction assembly 5140 asbone screw 5010 is driven into the bone by screwdriver 5170. In thisexample, retraction assembly 5140 is positioned proximally of housing5300 and defines passage 5123 for receiving stylet 5150 therethrough.Retraction assembly furthers includes an internally threaded portion forengaging threaded portion 5159 control device 5000 as described above inconnection with control device 4120, stylet 5150 is rotationally coupledto screwdriver 5170 such that when screwdriver 5170 and thus stylet 5150rotates in a clockwise manner, the engagement of threaded portion 5159of stylet 5150 and internally threaded portion of retraction assembly5140 causes proximal axial advancement of stylet 5150, e.g. retraction.Because the screwdriver is also rotating, this causes the bone screw5010 to be driven into bone at the same time as stylet 5150 retracts.The pitch of the threads of threaded portion 5159 of stylet 5150 and thethreads of bone screw 5010 may match to facilitate movement in oppositedirections at the same rate.

FIG. 58 shows drill 5270 which may alternatively be utilized inconjunction with control device 5000 rather than the screwdriver/bonescrew, described in connection with FIGS. 55-57 . Drill 5270 definespassage 5275 for receiving stylet 5150 therethrough. In this example,stylet 5150 is ultrasonically advanced through drill 5270 and into boneto create an initial pilot hole. The stylet is then retracted viaretraction assembly 5140, and drill 5270 is advanced into bone.

FIG. 59 shows control device 6000 which is another embodiment of adevice for advancing and retracting a stylet and is similar in mostrespects to control device 5000, the similar features of which will notbe described again. Control device 6000 includes housing 6300 whichoperatively connects to a separate, non-integral ultrasound transducerdevice 6270 to impart the ultrasonic vibrations to advance thescrewdriver or drill into bone.

Robotic systems may be used throughout the pre-operative andintra-operative stages of the surgery.

Preoperative planning for surgeries may include determining the bonequality in order to optimize bone preparation. Bone quality information,such as bone density or elastic modulus, can be ascertained frompreoperative scans, e.g. CT scans. The bone quality data can be used todetermine optimal properties for effective implant engagement. Examplesof such methods are found in U.S. Pat. No. 10,166,109 to Ferko, filed onSep. 18, 2014, entitled “Patient Specific Bone Preparation forConsistent Effective Fixation Feature Engagement,” U.S. PatentApplication Publication No. 2015/0119987 to Davignon et al., filed onOct. 28, 2014, entitled “Implant Design Using Heterogeneous BoneProperties and Probabilistic Tools to Determine Optimal Geometries forFixation Features,” and U.S. Pat. No. 10,070,928 to Frank et al., filedon Jul. 1, 2015, entitled “Implant Placement Planning,” each of which ishereby incorporated by reference herein in its entirety. In addition topreoperative imaging, robotic surgery techniques may employ imaging,such as fluoroscopy, during surgery. In such cases, systems integratingthe surgical system with the imaging technologies facilitate flexibleand efficient intraoperative imaging. Exemplary systems are described inU.S. Pat. No. 10,028,788 to Kang, filed on Dec. 31, 2013, entitled“System for Image-Based Robotic Surgery,” hereby incorporated byreference herein in its entirety.

As in the instant case, robotic systems and methods may be used in theperformance of spine surgeries to place implants in the patient's spineas in, for example, U.S. Patent Application Publication No. 2018/0325608to Kang et al., filed on May 10, 2018, entitled “Robotic Spine SurgerySystem and Methods,” the disclosure of which is hereby incorporated byreference herein in its entirety. The robotic system generally includesa manipulator and a navigation system to track a surgical tool relativeto a patient's spine. The surgical tool may be manually and/orautonomously controlled. Examples of robotic systems and methods thatemploy both a manual and a semi-autonomous are described in U.S. Pat.No. 9,566,122 to Bowling et al., filed on Jun. 4, 2015, and entitled“Robotic System and Method for Transitioning Between Operating Modes,”and U.S. Pat. No. 9,119,655 to Bowling et al., filed on Aug. 2, 2013,entitled “Surgical Manipulator Capable of Controlling a SurgicalInstrument in Multiple Modes,” each of which is hereby incorporated byreference herein in its entirety.

A robotic controller may be configured to control the robotic arm toprovide haptic feedback to the user via the robotic arm. This hapticfeedback helps to constrain or inhibit the surgeon from manually movingthe screwdrivers 4170, 8170 of systems 4000, 8000 beyond predefinedvirtual boundaries associated with the surgical procedure. Such a hapticfeedback system and associated haptic objects that define the virtualboundaries are described in, for example, U.S. Pat. No. 9,002,426 toQuaid et al., filed on Jun. 23, 2008, entitled “Haptic Guidance Systemand Method,” and U.S. Pat. No. 8,010,180 to Quaid et al., filed on Dec.21, 2012, entitled “Systems and Methods for Haptic Control of a SurgicalTool,” and U.S. Pat. No. 10,098,704 to Bowling et al., filed on May 18,2016, entitled “System and Method for Manipulating an Anatomy,” each ofwhich is hereby incorporated by reference herein in its entirety.

In some cases of autonomous positioning, a tool center point (TCP) of asurgical tool, such as screwdriver 4170, 8170, is brought to within apredefined distance of a starting point of a line haptic object thatprovides the desired trajectory. Once the tool center point is withinthe predefined distance of the starting point, actuation of an inputcauses the robotic arm to autonomously align and position the surgicaltool on the desired trajectory. Once the surgical tool is in the desiredposition, the robotic system may effectively hold the rotational axis ofthe surgical tool on the desired trajectory by tracking movement of thepatient and autonomously adjusting the robotic arm as needed to keep therotational axis on the desired trajectory. Such teachings can be foundin U.S. Patent Application Publication No. 2014/0180290 to Otto et al.,filed on Dec. 21, 2012, entitled “Systems and Methods for Haptic Controlof a Surgical Tool,” which is hereby incorporated by reference herein inits entirety.

During operation of a robotic surgical system, the operation of thesurgical tool can be modified based on comparing actual and commandedstates of the tool relative to the surgical site is described in U.S.Patent Application Publication No. 2018/0168750 to Staunton et al.,filed on Dec. 13, 2017, entitled Techniques for Modifying Tool Operationin a Surgical Robotic System Based on Comparing Actual and CommandedStates of the Tool Relative to a Surgical Site,” which is herebyincorporated by reference herein in its entirety. Further, roboticsystems may be designed to respond to external forces applied to itduring surgery, as described in U.S. Patent Application Publication No.2017/0128136 to Post, filed on Nov. 3, 2016, entitled “Robotic Systemand Method for Backdriving the Same,” which is hereby incorporated byreference herein in its entirety.

Further, because of the non-homogeneity of bone, applying a constantfeed rate, a uniform tool path, and a constant rotational speed may notbe efficient for all portions of bone. Systems and methods forcontrolling tools for such non-homogenous bone can be advantageous asdescribed in U.S. Pat. No. 10,117,713 to Moctezuma de la Barrera et al.,filed on Jun. 28, 2016, entitled “Robotic Systems and Methods forControlling a Tool Removing Material From a Workpiece,” which is herebyincorporated by reference herein in its entirety.

Although the invention herein has been described with reference toparticular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles and applications of thepresent invention. It is therefore to be understood that numerousmodifications may be made to the illustrative embodiments and that otherarrangements may be devised without departing from the spirit and scopeof the present invention as defined by the appended claims.

1. A method of inserting a fastener, comprising: positioning a portionof a stylet within a cannulated shaft of the fastener; advancing a tipof the stylet through a first bone and into a second bone; advancing aleading end of the fastener along the stylet through the first bone andinto the second bone; and removing the stylet from the cannulated shaftof the fastener and the bone.
 2. The method of claim 1, wherein the stepof advancing the tip of the stylet includes traversing a gap between thefirst bone and the second bone.
 3. The method of claim 2, wherein thestep of advancing the leading end of the fastener includes traversingthe gap between the first bone and the second bone along the stylet. 4.The method of claim 1, wherein the first bone and the second bone arerespective vertebral pedicles.
 5. The method of claim 1, wherein thestep of advancing the tip of the stylet includes advancing the tip ofthe stylet into the second bone to a first depth.
 6. The method of claim5, wherein the step of advancing the leading end of the fastenerincludes advancing the leading end of the fastener into the second boneto a second depth, wherein the second depth is less than the firstdepth.
 7. The method of claim 1, wherein the step of advancing the tipof the stylet includes pushing and/or oscillating the stylet through thefirst bone and into the second bone.
 8. The method of claim 7, whereinthe step of advancing the leading end of the fastener includes rotatingthe fastener to engage threads of the fastener with the first bone andthe second bone.
 9. The method of claim 1, wherein the step of advancingthe leading end of the fastener includes maintaining a stationaryposition of the stylet in the first bone and the second bone.
 10. Themethod of claim 1, wherein the step of advancing the tip of the styletis performed by a robotic end effector.
 11. A method of inserting afastener, comprising: positioning a portion of a stylet within acannulated shaft of the fastener; advancing a tip of the stylet into abone to a first depth without advancing the fastener into the bone;advancing a leading end of the fastener along the stylet into the boneto a second depth without further advancing the stylet into the bone;and removing the stylet from the cannulated shaft of the fastener andthe bone.
 12. The method of claim 11, wherein the step of positioningthe portion of the stylet includes positioning the portion of the styletwithin a channel of the cannulated shaft of the fastener.
 13. The methodof claim 11, wherein the step of advancing the tip of the styletincludes forming a pilot hole into the bone with the stylet.
 14. Themethod of claim 11, wherein the step of advancing the tip of the styletincludes maintaining a leading end of the fastener at or above a surfaceof the bone.
 15. The method of claim 11, wherein the first depth isbetween 5 to 30 millimeters.
 16. The method of claim 11, wherein seconddepth is less than the first depth.
 17. The method of claim 11, whereinthe step of advancing the leading end of the fastener includes thestylet remaining axially fixed within the bone.
 18. The method of claim11, wherein the step of advancing the tip of the stylet is performed bya robotic end effector.
 19. The method of claim 11, wherein the step ofadvancing the tip of the stylet includes pushing and/or oscillating thestylet through the bone.
 20. The method of claim 19, wherein the step ofadvancing the leading end of the fastener includes rotating the fastenerto engage threads of the fastener with the bone.